The Biostatistics Core Unit will serve as a resource and collaborator for all scientific projects associated with this SCCOR proposal. Specifically, the Core will collaborate with investigators on the experimental design of each protocol and on the design of questionnaires and forms. The Core Director will provide ongoing advice and recommendations regarding the statistical, sample size, and data quality implications of protocol design issues and of proposed protocol modifications. The Core will work with investigators in designing data entry systems, building quality control measures into those systems, and will be responsible for overseeing or conducting the statistical analyses of all clinical data generated by this project. Finally, the Core will work with the Coordinating Center (CC) of the 15-site Cardiovascular Outcomes Research Consortium (CORC) (Project 4) in facilitating the entry of Washington University's data into the web-based system the CC will design, will provide scientific expertise and software resources to assist with the statistical analysis of all aspects of the genomics work of projects 4 and 5, and will work with the CC in analyzing centralized CORC clinical data when manuscripts are of particular interest to Washington University investigators.